Our candidates are engineered using best-in-industry antibody discovery capabilities and are designed to maximize potency and duration of effect. Our portfolio includes multiple, non-competing antibodies with distinct binding targets, enabling a strategy that can avoid viral escape. Our lead program is expected to enter the clinic by the end of 2020.

Responsibilities:

• Responsible for the management and tactical execution of the regulatory CMC activities and ensuring that all applicable CMC-related regulations and guidelines are followed in the US and globally.
• Provide strategic guidance into the development of robust CMC strategies across all product life cycle.
• Perform regulatory assessment of change controls, deviations and GMP investigations. Manage multiple concurrent projects and provide project updates on set intervals.
• Manage timelines in cooperation with SMEs and project management to ensure on-time regulatory submissions.
• Assist with the planning, scientific writing and perform critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements to ensure a high quality regulatory submission and approval.
• Assist in review of manufacturing change controls by cross-checking the description in regulatory filings in INDs/IMPDs, CTAs and BLAs/MAAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements.
• Support establishing, managing and maintaining a knowledge base of current and emerging CMC regulatory requirements and guidelines.
• Assist in tracking of CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs.
• Participate, as needed, in planning, organizing and managing the CMC content of meetings with regulatory agencies.
• Participate in CMC project team meetings and provide current regulatory requirements that pertain to stability studies and analytical characterization tests.

Competencies:

• Self-motivated, detail oriented and good problem-solving skills
• Ability to multi-task in a fast-paced environment with changing priorities
• Excellent verbal /writing skills and ability to influence across multiple functions
• Ability to work independently with a strong attention to detail
• Excellent written and verbal communication and collaboration skills

Requirements:

• Requires a Bachelor of Science degree plus a minimum of 8-10 years of industry experience in US regulatory CMC activities or equivalent combination of education and experience.
• Knowledge of global (US, EU, ROW, ICH, etc.) regulatory requirements.
• Biologics CMC submission experience preferred
• Must be able to demonstrate the ability to apply knowledge strategically and operationally across all projects.
• Experience working in a matrix environment: strong negotiation skills, able to communicate sound regulatory advice based on regulations as well as the business needs.
• Previous experience in providing regulatory assessment of change controls, deviations and GMP investigations. LESS…

The position requires a strong background in Analytical Development and a thorough knowledge of cGMPs ICH and relevant FDA guidelines. Responsibilities include development, validation, qualification, transfer of analytical methods, support stability study design and trend analysis, leading analytical characterization and comparability studies as well as studies in support of product development activities and QC support. She/he will facilitate the creation of fundamental product and process understanding and use state-of-the-art instrumentation to facilitate the advancement of drug development. Support for drug candidates across all stages of development will be required and experience with late stage /BLA programs is highly desired.

Summary of Key Responsibilities:

• Support the external development of robust validatable analytical methods
• Manage and oversee review of raw data packages associated with method qualifications/validations, release testing, stability testing, and other characterization testing of drug substances and drug products.
• Support process characterization and process validation activities.
• Support relevant vendors (CMOs/CTLs) during the development and characterization of the drug substance and drug product. Travel to CMOs and CTLs as needed (when safe and appropriate).
• Support bioassay development and validation, structure / function characterization studies of biologics
• Support drug product formulation and process development including characterization of the process and finished product.
• Develop and ensure the delivery of high-quality documentation to meet global regulatory expectations for analytical methods and controls. Address technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
• Provide regulatory strategy input regarding characterization and analytical comparability programs. Provide technical support to Quality Control group.
• Identify staffing needs and recruits/hires/promotes personnel as appropriate.
• Apply technical and management expertise to meet project goals and timelines, and to make technical and management decisions to keep projects on track.

Qualifications:

The successful candidate has a broad understanding of analytical sciences and regulatory/GMP requirements, and a proven track record in analytical development for different clinical stage programs. Excellent communication and collaboration skills in a cross-functional and fast-paced environment as well as a proven ability to achieve results with external laboratories and manufacturing facilities are a must. Other requirements include:

• Demonstrated and significant experience with analytical development and support of clinical and commercial protein-based biologics, preferably monoclonal antibodies. Preference given to candidates with late clinical stage development experience.
• Advanced degree in Biochemistry or related field, PhD preferred but not required
• 10+ years of relevant analytical experience for biologics in the pharmaceutical industry including experience with regulatory filings.
• Remote work location. While geography is not important, the Head must be typically available during normal Eastern US time zone working hours. Some conference calls outside of work hours is expected. LESS…

Responsibilities:

• Design and execute stability protocols for DS and DP
• Review all stability data /reports and update stability tables accordingly.
• Perform trending analysis of stability data and facilitate timely investigation of OOT & OOS occurrences
• Compile and write Annual Product Reviews for products, as necessary.
• Support drafting of stability updates for regulatory filings including INDs and IND annual reports
• Provide support to coordinate completion of stability and other analytical technical reports internally and at contract GMP testing laboratories / contract development and manufacturing organizations
• Participate in establishment of drug substance and drug product specifications
• As part of the Quality Control department, provide technical and documentation support for all testing-related documentation (release and stability test methods, stability protocols, stability reports, expiry establishment, method validation protocols and reports).

Competencies:

• Excellent written and oral communication skills, with the ability to communicate complex information and ideas
• Strong attention to detail
• Strong organizational skills with the ability to effectively multi-task and prioritize
• Resourceful, flexible, self-starter with the ability to work effectively in a dynamic, fast-paced, and entrepreneurial environment
• Ability to flexibly adapt to changing business needs and meet timelines
• Ability to work independently and on a team
• Ability to effectively collaborate with internal and external stakeholders

Requirements:

• Bachelor’s or Master's degree in a scientific discipline
• 3 – 5 years experience in the biopharmaceutical industry experience in a Quality Control or Quality Assurance function
• Experience managing stability programs
• High proficiency with MS Excel & Word and statistical trend analysis
• Previous experience working with external testing laboratories LESS…

You must be able to effectively manage a cross-functional team in a matrixed, fast-paced environment, proactively identify and communicate program status/risks/opportunities and possess exceptional group facilitation and problem-solving skills. This position will report to the Vice President, Strategy & Operations, Head of Program and Alliance Management.

Responsibilities:

Serve as Program Manager for Adagio’s cross-functional drug development program teams, applying program management best practices to :

• Work with team leadership to develop and maintain high quality, integrated global development plans; serve as subject matter expert on program activity interdependencies with significant focus on the critical path
• Lead the development of program goals with the team leader; monitor team progress to goals
• Co-chairs timely, efficient, action-oriented development team meetings; responsible for coordinating team communications and operations
• Monitor progress on program activities to program critical path and decision criteria to meet key milestones and goals across all functions; proactively identify issues and facilitate resolution
• Ensure streamlined communication and alignment between program team, sub-teams, and functional leaders
• Drive and maintain robust decision criteria and risk management plan in collaboration with program team and program leader
• Liaise with program leader and finance to develop and manage an integrated program budget, including inputs for long range financial planning
• Facilitate scenario planning exercises as needed
• Identify and communicate deviations from planned timing, budget, and/or scope that could impact short and long-term program success and value creation potential
• Able to express ideas and present information effectively; develop communications and presentations relating to program strategy, status, critical path activities, resource requirements, and related issues and/or risks for a variety of audiences, including senior management
• Manage ongoing program team and subteam operations (develop agenda and objectives, capture and disseminate meeting outcomes (decisions, agreements, actions); follow up on critical or time sensitive actions with respective owners, maintain team collaboration space (Sharepoint))

Qualifications and Experience:

• A highly motivated, detail oriented, and collaborative individual with a Bachelor’s degree in a scientific or related discipline
• Minimum of 8 years of relevant work experience, including at least 3 years managing drug development programs
• Advanced understanding of program management principles and the essential activities of all disciplines involved in drug development
• A demonstrated ability to effectively manage teams in a highly cross-functional, fast-paced, rapidly evolving environment; must be able to partner effectively with program leader, team members, and key stakeholders across the organization
• Experience driving teams to ensure execution of plan within timeline, scope and budget
• Proven analytical and technology skills, including proficiency in project planning tools (MS Project, Smartsheets, etc.), content management tools, and the Microsoft Office Suite; ability to critically interrogate program plans
• Exceptional leadership, negotiation, interpersonal, oral, and written communication skills
• PMP certification a plus but not required
• Experience in infectious diseases and/or biologics preferred but not required LESS…

This position will also be responsible for coordinating, controlling, and continuously improving the internal quality assurance processes, primarily related to clinical development and related activities and systems. The Sr. Director will coordinate audits to support GCP and other regulated activities and lead strategy and activities in support of health authority inspections. The individual will ensure compliance of clinical trials and development activities to global regulatory standards including FDA, EMA, and other international regulatory agencies.

Key Responsibilities:

• Build the Clinical Development Quality Assurance and Compliance function and infrastructure to support Adagio pipeline and other compliance-related activities such as GDPR compliance
• Develop a risk-based audit program to conduct effective audits of internal processes, investigator sites, and vendors that support development activities
• Create, implement and maintain efficient, phase-appropriate and compliant GCP systems
• Partner with stakeholders to develop GCP-focused SOPs, policies and procedures consistent with corporate objectives
• Partner with other stakeholders within Adagio (i.e. CMC) to build cross-functional and corporate policies and procedures and integration of systems/activities, when appropriate
• Assist the Clinical Development organization in establishing procedures to support a risk-based approach to oversight of clinical trials using principles of quality by design and quality risk management
• Provide QA Support for Clinical Vendor/CRO oversight:
  • Represent Adagio QA on Sponsor/CRO/Site project calls and provide updates to Management
  • Provide QA support for critical quality issues, protocol deviations and investigations
• Assist in the development and implementation of GCP training programs and conduct training sessions as required
• Establish quality procedures and tools in support of audit and compliance activities
• Collaborate with key stakeholders in development and implementation of internal and external GCP audit plans;
• Proactively identify potential quality issues/discrepancies and work with Management to effectively resolve in a compliant and timely manner;
• Research changes and updates to ICH, GCP regulations and assess impact on Adagio systems and practices;
• Assist in the preparation and coordination of internal and external stakeholder meetings
• Participate on cross-functional team meetings as QA Subject Matter Expert
• Lead activities in support of health authority inspections
• Review regulatory documents and check for consistency and compliance with relevant regulations, standards and best practices

Competencies:

• Excellent written and oral communication skills, with the ability to communicate complex information in a virtual environment;
• Ability to work in a team and independently
• Strong organizational skills with the ability to effectively multi-task and prioritize;
• Ability to flexibly adapt to changing business needs and meet timelines;
• Ability to analyze & interpret analytical data;
• Ability to determine impact of issues on subjects, study conduct, clinical program development and company needs based on stage of development and risk profile
• Strong attention to detail and good problem-solving skills;
• Resourceful, self-starter and team player with a strong results orientation.

Requirements :

• A Bachelor’s degree in a scientific discipline or biotechnology field;
• A minimum of 10 years relevant GCP experience in pharma/biotech company, working within quality systems and regulated GCP/ICH environments;
• Experience leading and facilitating inspection readiness activities and hosting FDA and other regulatory agency inspections;
• Experience managing internal and external audits,
• Strong understanding of GCPs, FDA, EU and ICH regulatory standards/guidance documents;
• Extensive knowledge of risk-based quality systems approaches, with a focus on ICH E-6 R2 GCP principles;
• Ideally will also have experience in facilitating/participating in remote audits and quality activities; able to travel to Clinical sites/vendors as required; Travel Requirement expected to be 25%. LESS…

Responsibilities

• Facilitate and manage interaction and meetings within Tech Ops and with outside vendors including agendas and minutes, action items. As required, interact with outside collaborators and partners to ensure alignment, reach consensus and drive timely decision making.
• Facilitate cross-functional integration and alignment between all Tech Ops functions including process development, analytical, formulation, manufacturing, quality, and supply chain. Maintain and administer timelines to ensure on-time deliverables for the group.
• In collaboration with Tech Ops leadership, create the Tech Ops project plan (both short and long term) and ensure alignment and integration into overall Program Plan(s). Actively manage the plan, timelines and deliverables including tracking of project milestones, and driving near-term team decision-making with input from Program Team(s).
• Develop and execute Tech Ops project specific risk management exercises such that project risks are systematically defined, quantified, assessed and appropriately mitigated.
• Plan/Manage Tech Ops specific budgets, track expenditures and resource usage.
• Assist with management of documents to support internal information management.

Requirements:

• BS/BS in a Life Science with a minimum of 7+ years industry experience specifically in cross-functional management within Tech Ops, preferably manufacturing or development.
• Outstanding interpersonal skills. Excellent verbal and written communication skills.
• Outstanding organizational skills. Ability to prioritize work and take initiative when necessary.
• Ability to work well with external collaborators with professionalism and discretion
• A thorough understanding of the science and technology associated with biopharmaceutical product development, manufacturing, quality function, and clinical use.
• Strong organization skills
• Understanding of Tech Ops activities, including function interdependence at all stages of development
• Experience in establishing and managing external CDMOs / CROs in coordination with Tech Ops Technical leads to ensure timely delivery of clear, accurate and well written reports.
• Strong knowledge of drug development and FDA/ICH guidance documents regarding GMP regulations
• Outstanding software skills, particularly Microsoft Project / Smartsheet and the Microsoft Office suite. LESS…

Responsibilities:

• Strong background and experience in analytical method development and validation activities for protein-based biotherapeutics, including monoclonal antibodies.
• Experience selecting and working with contract laboratories to carry out analytical development and validation activities to enable release and stability testing, including review and approval of method transfer/validation protocols, data analysis, and reports
• Oversight of analytical QC testing laboratories
• Establish specifications to support global clinical trial material manufacture and release for both drug substance and drug product.
• Oversight of cGMP QC-related activities and documents (change controls, deviations, CAPAs, procedures, QC raw data review, batch release support, stability protocols and programs, validation protocols, etc.)
• Oversee Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate
• Oversee and support critical quality attributes, setting of specifications, data trending on stability and shelf life and expiry dating of DS and DP
• Author QC sections of regulatory filings and provide technical support for responses to Health Authority comments
• Past experience with filing or working on INDs and BLAs preferred.
• Work with the Technical Operations team and with CMO personnel.
• Must be able to handle multiple projects and adjust to shifting priorities

Qualifications

• PhD in Analytical Biochemistry or Biochemistry or related disciplines with at least 10 years of industrial experience
• Expertise and experience in all aspects of QC including analytical development, method validation, technology transfer, specification establishment, and stability program administration for protein-based therapeutics.
• Ideal candidate has experience with regulatory interactions (FDA or EMA) including telecons and/or regulatory filings
• Strong interpersonal and communication skill set to effectively work with internal and external stakeholders LESS…

Responsibilities:

• Supports the creation of the clinical development plan in partnership with cross- functional team members as well as KOLs and CROs
• Authors and reviews study materials for clinical trial utilization and health authority submissions
• Analyzes and interprets clinical trial data, collaborating with program lead to conduct data review
• Troubleshoots internal and external conflicts to ensure trial integrity and success
• Scientific author / contributor to internal and external communications, such as protocol training, posters, publications, and advisory board meeting presentations.
• Working with the statistician, lead the development of statistical analysis plans
• Engages with trial sites and CROs on an on-going basis to monitor subject data and data collection status, resolve queries, ensure adherence to protocol, and evaluate consistency of data
• Support protocol design and development strategy for clinical pharmacology trials
• Manage third-party CROs and consultants as necessary, including bioanalytical and biomarker laboratories, statisticians, pharmacokineticists, and data management teams
• Collaborate with the medical monitor to evaluate patient and program level safety data
• Maintains knowledge of the therapeutic area, current medical practice, and pharmaceutical regulations to help ensure best practices

Competencies:

• Ability to proactively predict issues, resolve problems, and make sound decisions
• Excellent oral and written skills; ability to effectively communicate complex information
• Ability to analyze and interpret clinical data
• Strong organizational abilities and attention to detail
• Ability to work independently and on a team
• Ability to effectively collaborate with remote colleagues, internal and external stakeholders
• Strong understanding of the clinical research process through Phase I-III trials

Requirements:

• Bachelor’s degree in science with 7+ years related experience or
• Master’s degree and 5+ years related experience; Clinician preferred (RN, NP, PA, PharmD, or MD)
• Understands scientific & clinical research process
• Experience in infectious diseases or immunology preferred but not required LESS…